AccessGUDID - DEVICE: BREMER HIFIX (10705034341941)

GUDID

Device Identifier (DI) Information

Brand Name: BREMER HIFIX
Version or Model: HT035HI
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HT035HI
Company Name: DEPUY SPINE, LLC

Primary DI Number: 10705034341941
Issuing Agency: GS1
Commercial Distribution End Date: June 20, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 107105876 *Terms of Use

Device Description: BREMER CROWN & RING ACCESSORY SYSTEM W/HIFIX SMALL CROWN 19-23 in. (48-58 cm)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60367	Cervical spine immobilization system, single-use	An assembly of orthopaedic devices designed to immobilize the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. Commonly known as a Halo vest, it typically consists of a ring(s) around the head (the halo) which is attached to the skull with threaded bolts, a special padded vest/harness, four rods with locking mechanisms connecting the head ring to the vest, together with the appropriate instrumentation. This device may be made of ferrous or non-ferromagnetically active materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JEC	COMPONENT, TRACTION, INVASIVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K915800	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1767713f-4e73-4b25-b39a-be1955dfd696
Public Version Date: July 06, 2018
Public Version Number: 5
DI Record Publish Date: September 24, 2015